It’s Not Easy Eating Greens

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In the largest multistate food-borne E. coli outbreak since 2006, at least 84 people across 19 states have been infected with E. coli from romaine lettuce in the past month. The team at TWTW is counting ourselves lucky that we are unusually big fans of kale. In other news:

The gift that keeps on giving: Since an estimated 25% of kidney transplant patients die with perfectly good organs, a UCLA surgeon has proposed an unexpected “solution” to the national shortage of kidney donations: “re-gifting” kidneys from previous transplant patients.

One shot cures: A Goldman Sachs issues a report this week about the economic sustainability of one shot therapies. The report questions whether reduced revenue from curative therapies will justify the cost of research and clinical trials, particularly for rare diseases, which typically run at least $1 billion.Read on for The Week That Was …

►SCOTUS KOs IPR Challenge

The Supreme Court disappointed the pharmaceutical industry this week when it upheld the Constitutionality of Inter Partes Reviews (IPR)—an alternative to litigation for patent challenges. Plaintiffs in the case argued only the judicial branch can review patent legality, and that the political appointees at the US Patent and Trade Office should not have the authority revoke patents through a separate process. The Court disagreed in a 7-2 ruling, but the industry can still work to change the structure of the IPR process through Congress and the administration.Our TakeMarket exclusivity and the use of patents to perpetuate it are becoming a more significant part of the public drug pricing debate. While IPR is meant to target patent trolls in IT, healthcare consumers are becoming more savvy about patent issues—and what they mean for drug costs and the speed of generics entries to market. Companies that are pronounced in their IP actions for investors can expect to be asked—and scrutinized—about patient issues by other audiences. If your company is defending against patent challenges, think beyond legal responses to demonstrate the added value (through advances in research, training, care management tools, and support) that you’ve developed throughout the life of the drug.

►COPAY Assistance Conundrum

Although drug co-pay assistance organizations were developed help patients shoulder the growing burden of out-of-pocket costs for prescriptions, federal authorities are currently investigating the groups for profiting off of high drug costs. The HHS Inspector General and the U.S. Attorney in Massachusetts have been reviewing insurance copay assistance programs for the past three years, looking for violations of anti-kickback laws that prohibit drug companies from covering copays for Medicare patients and assistance groups from “steering” patients to drugs manufactured by their benefactors. At issue is whether copay assistance programs “mask” the price of drugs, forcing higher costs to insurance companies, which, in turn, pass the costs to consumers and employers. The feature, which ran in USA Today, notes that the funding for these groups comes almost entirely from drug companies.The role of co-pay charities was further highlighted this week by the Washington Post,which provided a snapshot of the life of one of the patients who benefits from these financial assistance programs, Loukisha Olive-McCoy. Mrs. McCoy suffers from hereditary angioedema and requires weekly injections of life-saving medication each valued at more than one year’s rent of their family home. Without these assistance programs, Mrs. McCoy wouldn’t be able to afford her treatments.OUR TAKEThe complex relationship between pharmacos, co-pay charities and payers has been receiving increasing scrutiny by policymakers and media alike. As more precision medicines are developed and co-pay costs continue to rise, policymakers and the public are demanding more visibility into pricing. We advise clients to share information about how these programs provide real, meaningful value and support to patients. And make eligibility criteria for assistance—as well as relationships with and donations to patient assistance charities—crystal clear. Transparency is the watchword for pharma. Pharmaceutical companies that report their donations and communicate openly about these relationships have a better chance to break even in today’s reputation battle.